Study Stopped
Researcher left university before the start of recruitment
Developing an Intervention to Improve the Non-Technical Skills of the Cardiac Surgical Teams
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Teams of several medical professionals conduct high-risk cardiac surgical procedures. These professionals work in complex, stressful operating room environments requiring effective communication and teamwork skills. Surgeons, anesthesiologists, perfusionists, nurses, and surgical technicians working in this environment are also vulnerable to human errors. Non-technical skills for surgeons (NOTSS), defined as cognitive skills (situation awareness, decision making) and social skills (leadership, communication, and teamwork) underpinning medical knowledge and technical skills, are essential contributors to better cardiac surgery outcomes. Yet most of the surgical education programs focus only on technical skills, and interventions to improve the non-technical skills of cardiac surgical teams are scarce. The proposed research will develop and pilot-test and evaluate the preliminary effectiveness of an intervention to improve the non-technical skills of cardiac surgical teams.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2025
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
April 27, 2025
January 1, 2024
5 years
January 29, 2024
April 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Non-technical skills behaviors of the members of the cardiac surgical teams
Investigators will use the Non-Technical Skills for Surgery (NOTSS) rating tool to evaluate the effectiveness of the non-technical skills educational intervention on participants' intraoperative non-technical skills.
Non-technical skills will be measured before the intervention, immediately after the intervention, and six months after the intervention
Secondary Outcomes (2)
Intraoperative performance of the cardiac surgical teams
For each of the cardiac surgeons who will participate in the study, the investigators will compare baseline data (six months collected before implementing the NOTSCS intervention), with data collected after the NOTSCS intervention (six months data).
Rate of patients with patients with intraoperative bleeding requiring transfusion, and unplanned return to the operating room
Data for six months before and six months after the intervention
Study Arms (2)
Non Technical Skills for Cardiac Surgery (NOTSCS) intervention group
EXPERIMENTALThese are the members of the cardiac surgical teams who will be trained in the non-technical skills.
Control group
NO INTERVENTIONThese are members of the cardiac surgical teams who will not participate in the intervention.
Interventions
Participants will participate in a simulation-based mastery learning of the non-technical skills.
Eligibility Criteria
You may qualify if:
- All members of the cardiac surgical teams will be eligible to participate in the study (cardiac surgeons, OR nurses, perfusionists, anesthetists...
You may not qualify if:
- Clinicians who are not directly involved in intraoperative care of cardiac surgical patients ( for example nurses working only in the recovery room, ICU, floor)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Investigators will record videos of the participants during simulation sessions, before and after the interventions. The people assessing the non-technical skills of the cardiac surgical teams will be masked if the videos were recorded before or after the intervention.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2024
First Posted
February 14, 2024
Study Start
June 1, 2025
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
April 27, 2025
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available upon completion of the study
- Access Criteria
- Data will be shared upon contacting the PI
The findings from this study will be at national and international conferences. Additionally, the study team will publish findings from this study in the peer-reviewed scientific journals. Along with publication, cardiac surgery-specific non-technical skills assessment tools, simulation scenarios, and debriefing templates that will be developed in this study, will be shared with the scientific community so that they can understand the process of developing and implementing this project, and possibly replicate it if they are interested. The datasets and coding book, and STATA codes will be shared to the scientific community. Quantitative data generated from this project will be made available as soon as the article gets published online. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.